New Delhi: Brazil’s health regulator has denied permission to import Covaxin, the Covid vaccine produced by indigenous firm Bharat Biotech. Twenty million doses of the vaccine has been ordered by Brazil, the nation hit worst by Covid after the United States.
According to reports, a Brazilian government gazette had said that Covaxin had been rejected “considering the non-compliance with the requirements of Good Manufacturing Practices for Medicines”.
In its response, Bharat Biotech has told NDTV: ”The requirements pointed out during inspection will be fulfilled, the timelines for fulfilment is under discussion with the Brazil NRA and will be resolved soon.”
Covaxin, produced by Bharat Biotech in collaboration with the Indian Council for Medical Research, was approved for emergency use by the national drug regulator in January. The vaccine was expected to be used only in the “clinical trial mode”.
Earlier this month, it was taken off clinical trial mode after the authorities said vaccine has showed an interim efficacy of 81 per cent in the Phase 3 clinical trials in India.
Bharat Biotech said the vaccine is effective against the UK variant of the virus. The government has said the need to change the composition of Covaxin has not been felt yet in view of its efficacy against the mutant variants.
Two other countries — Nepal and Zimbabwe — have approved Covaxin for emergency use. Bharat Biotech had also applied for clearance in Brazil, Thailand and the Philippines.
Bharat Biotech says around 40 countries have expressed interest in Covaxin.